Completed

A Pilot Trial Of Valproic Acid In Patients With Kaposi's Sarcoma

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What is being tested

Data Collection

Who is being recruted

DNA Virus Infections+7

+ Herpesviridae Infections

+ Infections

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: February 2005
See protocol details

Summary

Principal SponsorAIDS Malignancy Consortium
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2005

Actual date on which the first participant was enrolled.

OBJECTIVES: Primary * Determine the safety of valproic acid in patients with Kaposi's sarcoma. * Determine the effects of this drug on human herpes virus 8 (KSHV) gene expression using polymerase chain reaction and immunohistochemistry in these patients. Secondary * Determine the effects of this drug on HIV, KSHV, and Epstein-Barr virus viral loads in the plasma and peripheral blood mononuclear cells of these patients. * Determine clinical response in patients treated with this drug. OUTLINE: This is an open-label, pilot, multicenter study. Patients receive oral valproic acid twice daily on days 1-28 followed by a drug taper over 2 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for 6 months. PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 1 year.

Official TitleA Pilot Trial Of Valproic Acid In Patients With Kaposi's Sarcoma 
NCT00075777
Principal SponsorAIDS Malignancy Consortium
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

19 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

DNA Virus InfectionsHerpesviridae InfectionsInfectionsNeoplasmsNeoplasms by Histologic TypeNeoplasms, Vascular TissueSarcomaSarcoma, KaposiVirus DiseasesNeoplasms, Connective and Soft Tissue

Criteria

DISEASE CHARACTERISTICS: * Histologically confirmed HIV-related Kaposi's sarcoma (KS) * Disease involving the skin and/or lymph nodes * No symptomatic visceral disease * No oral KS as the only site of disease * Slowly progressive or stable disease allowed * Slow progression defined as fewer than 5 new lesions per month * Must have documented HIV infection by positive ELISA, western Blot, or viral load determination * CD4 T-cell count \> 50/mm\^3 PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 60-100% Life expectancy * At least 3 months Hematopoietic * Hemoglobin ≥ 8.0 g/dL * Absolute neutrophil count ≥ 750/mm\^3 * Platelet count ≥ 75,000/mm\^3 Hepatic * Bilirubin ≤ 1.5 times upper limit of normal (ULN)\* * AST and ALT ≤ 3 times ULN * Albumin \> 2.5 g/dL NOTE: \*Elevated total bilirubin (≤ 3.5 mg/dL) secondary to indinavir therapy allowed provided the direct bilirubin is normal Renal * Creatinine \< 1.5 times ULN Cardiovascular * No prior myocardial infarction * No evidence of cardiac ischemia Other * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study participation * No prior lactic acidosis \> 2.0 mmoles/L * No prior lipoatrophy or hypercholesterolemia secondary to retroviral treatment * No concurrent, acute, active opportunistic infection other than oral thrush or genital herpes within the past 14 days * No other concurrent neoplasm requiring cytotoxic therapy PRIOR CONCURRENT THERAPY: Biologic therapy * More than 2 weeks since prior biologic therapy for KS Chemotherapy * More than 2 weeks since prior chemotherapy for KS * No concurrent systemic cytotoxic chemotherapy Endocrine therapy * Not specified Radiotherapy * More than 2 weeks since prior radiotherapy for KS Surgery * Not specified Other * More than 2 weeks since other prior antineoplastic or local therapy for KS * More than 2 weeks since prior investigational therapy for KS * More than 60 days since prior local therapy to a KS-marker lesion unless lesion has clearly progressed since therapy * More than 1 year since prior valproic acid * Concurrent antiretroviral therapy allowed provided regimen has been stable for at least 4 weeks * No concurrent zidovudine * No other concurrent KS-specific therapy * No other concurrent investigational drugs, other than IND-approved antiretroviral agents

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 13 locations

Suspended

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, United StatesSee the location
Suspended

Veterans Affairs Medical Center - San Diego

San Diego, United States
Suspended

UCSF Comprehensive Cancer Center

San Francisco, United States
Suspended

Georgia Cancer Center for Excellence at Grady Memorial Hospital

Atlanta, United States
Completed13 Study Centers